An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2024
• Main ID: NCT03467958
• Date of registration: 12/03/2018
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
• Scientific title: A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
• Date of first enrolment: August 24, 2018
• Target sample size: 1200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03467958
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Moldova, Republic of, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

• Name: Recruiting sites have contact information. Please contact the site directly. If there is no contact information,

Key inclusion & exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit: www.BMSStudyConnect.com

Inclusion Criteria:

- Is not in clinical response or clinical remission after completing 12 weeks in the
Induction Studies

- Experience relapse or who complete the Maintenance Study

- Complete a study of ozanimod for Crohn's Disease and meet the criteria for
participation

Exclusion Criteria:

- Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological,
endocrine, psychiatric, or other major systemic disease making implementation of the
protocol or interpretation of the study difficult or that would put the subject at
risk by participating in the study

- Has suspected or diagnosed intra-abdominal or perianal abscess that has not been
appropriately treated

- Is receiving treatment with any of the following drugs or interventions: CYP2C8
inducers; Monoamine oxidase inhibitors

Other protocol-defined inclusion/exclusion criteria apply



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Ozanimod

Primary Outcome(s)

Proportion of participants with a CDAI score of < 150 [Time Frame: Up to 264 Weeks]

Secondary Outcome(s)

Proportion of participants with a CDAI score < 150 in participants off corticosteroids [Time Frame: Up to 264 Weeks]

Change from baseline in CDAI [Time Frame: Up to 264 Weeks]

Proportion of participants with a simple endoscopy score (SES-CD) decrease from baseline of = 50% [Time Frame: Up to 264 Weeks]

Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score of < 150 and SES-CD decrease from baseline of = 50% [Time Frame: Up to 264 Weeks]

Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50% [Time Frame: Up to 264 Weeks]

Proportion of participants with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10% [Time Frame: Up to 264 Weeks]

Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score of < 150 [Time Frame: Up to 264 Weeks]

Proportion of participants with average daily abdominal pain score = 1 point, and average daily stool frequency = 3 points with abdominal pain and stool frequency no worse than baseline [Time Frame: Up to 264 Weeks]

Proportion of participants with CDAI score of < 150 and SES-CD = 4 points and a SES-CD decrease = 2 points [Time Frame: Up to 264 Weeks]

Proportion of participants with SES-CD = 4 points and a SES-CD decrease = 2 points [Time Frame: Up to 264 Weeks]

Proportion of participants with average daily abdominal pain score = 1 point and average daily stool frequency = 3 points with abdominal pain and stool frequency no worse than baseline and SES-CD = 4 points and a SES-CD decrease = 2 points [Time Frame: Up to 264 Weeks]

Proportion of participants with CDAI reduction from baseline of = 70 points [Time Frame: Up to 264 Weeks]

Secondary ID(s)

U1111-1203-8203

2017-004295-55

RPC01-3204

Source(s) of Monetary Support

Please refer to primary and secondary sponsors